Phase 3
N=321
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT04294667 ↗Enrolled (actual)
321
Serious AEs
11.5%
Results posted
Apr 2025
Primary outcome: Primary: Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 — 34.6; 49.5 percentage of participants — p=0.0110
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DZP (Drug); Placebo (Other)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Biopharma SRL
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Achievement of BILAG 2004-based Composite Lupus Assessment (BICLA) Response at Week 48 |
34.6; 49.5 | 0.0110 sig |
| SECONDARY Percentage of Participants With Achievement of BICLA Response at Week 24 |
38.3; 46.6 | 0.1776 |
| SECONDARY Percentage of Participants With Achievement of BICLA Response at Week 12 |
29.0; 39.9 | 0.0518 |
| SECONDARY Percentage of Participants With Achievement of Prevention of Severe British Isles Lupus Assessment Group (BILAG) Flares (Severe BILAG Flare-free) Through Week 48 |
76.6; 88.4 | 0.0257 sig |
| SECONDARY Percentage of Participants With Achievement of Lupus Low Disease Activity State (LLDAS) in ≥50% of Post-Baseline Visits Through Week 48 |
15.9; 23.6 | 0.1042 |
| SECONDARY Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) at Week 48 |
-4.2; -6.1 | 0.0001 sig |
| SECONDARY Percentage of Participants With Achievement of BILAG Improvement Without Worsening at Week 48 |
34.6; 49.5 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment (PGA) at Week 48 |
-33.4; -39.6 | — |
| SECONDARY Percentage of Participants With Achievement of Systemic Lupus Erythematosus Responder Index Response - 4 (SRI-4) Response at Week 48 |
41.1; 60.1 | — |
| SECONDARY Percentage of Participants With Achievement of Prevention of Moderate/Severe BILAG Flares (Moderate/Severe BILAG Flare-free) Through Week 48 |
63.0; 78.6 | — |
| SECONDARY Time to Severe BILAG Flare Through Week 48 |
NA; NA | 0.0111 sig |
| SECONDARY Time to Moderate/Severe BILAG Flare Through Week 48 |
NA; NA | 0.0228 sig |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study |
75.0; 82.6 | — |
| SECONDARY Percentage of Participants With Serious Treatment-emergent Adverse Events During the Study |
14.8; 9.9 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events of Special Interest During the Study |
0.9; 0 | — |
| SECONDARY Percentage of Participants With Treatment-emergent Adverse Events of Special Monitoring During the Study |
24.1; 36.6 | — |
Summary
The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
Eligibility Criteria
Inclusion Criteria
- Rescreening will be allowed once during the study in case there is new evidence for an inclusion criterion that was not fulfilled at the first screening or in case a study participant no longer meets an exclusion criterion or screening period exceeded the maximum duration due to delays in screening processes
- Study participant must be ≥16 years of age, unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)
- Study participants who have moderate to severe disease activity due to either persisting active SLE or due to an acute worsening of SLE in the scope of frequent flaring/relapsing-remitting systemic lupus erythematosus (SLE) despite stable standard of care (SOC) medication defined as:
a. Diagnosed with SLE at least 24 weeks before the Screening Visit (Visit 1) study entry by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (in central laboratory at Screening) ii) Either complement C3 2.5 mg/dL, or participant has proteinuria >3 g/day, or protein: creatinine ratio >340 mg/mmol at the Screening Visit
Data sourced from ClinicalTrials.gov (NCT04294667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.